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ACTIVE NOT RECRUITING Phase 1

A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies

NCT05828589 · View on ClinicalTrials.gov ↗

Study Summary

This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Optimization."

Interventions

  • DRUG BGB-21447

Study Locations (20)

Jiangsu

  • The First Peoples Hospital of Changzhou — Changzhou
  • Jiangsu Province Hospital — Nanjing
  • The First Affiliated Hospital of Soochow University — Suzhou

Iowa

  • University of Iowa Hospitals and Clinics — Iowa City
  • Mission Cancer and Blood — Waukee

New York

  • Nyu Langone Health Perlmutter Cancer Center At Nyu Langone Hospital Long Island — Mineola
  • Laura and Isaac Perlmutter Cancer Center At Nyu Langone Health — New York

Queensland

  • Pindara Private Hospital — Benowa
  • Mater Cancer Care Centre — South Brisbane

Hubei

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan
  • Yichang Central Peoples Hospitaljiangnan Branch — Yichang

District of Columbia

  • Sibley Memorial Hospital Johns Hopkins Medicine — Washington D.C.

Maryland

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins — Baltimore

South Dakota

  • Avera Cancer Institute — Sioux Falls

Trial Details

FieldValue
Enrollment Target 112 participants
Start Date 2023-06-20
Est. Completion 2026-05
Phase Phase 1

Sponsor

BeOne Medicines

138 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05828589

The ClinicalTrials.gov registry entry for NCT05828589 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BeOne Medicines, which has 138 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Refractory Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which BGB-21447 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05828589 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Jiangsu, Iowa, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05828589 about?

NCT05828589 is a clinical study titled "A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies". This study is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminis...

What is the current status of trial NCT05828589?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2023-06-20. Estimated completion is 2026-05.

What conditions does trial NCT05828589 study?

This clinical trial studies the following conditions: Refractory Chronic Lymphocytic Leukemia, Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Follicular Lymphoma, Refractory Marginal Zone Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05828589?

The interventions under investigation include: BGB-21447 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05828589?

This trial is sponsored by BeOne Medicines, which has 138 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05828589 being conducted?

This trial has 20 study locations across District of Columbia, Iowa, Maryland, New York, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial